Opportunity Information: Apply for NV VSR 15 001
Apply for NV VSR 15 001
- The Office of the Assistant Secretary for Health in the health sector is offering a public funding opportunity titled "FY15 Research, Monitoring and Outcomes Definitions for Vaccine Safety" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.344 Research, Monitoring and Outcomes Definitions for Vaccine Safety.
- This funding opportunity was created on Mar 18, 2015 and posted on Jan 13, 2015.
- Applicants must submit their applications by Apr 15, 2015 No Explanation. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- none
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Opportunity Summary:
The FY15 Research, Monitoring and Outcomes Definitions for Vaccine Safety opportunity is a discretionary federal funding program from the Office of the Assistant Secretary for Health (OASH), managed through the National Vaccine Program Office (NVPO). NVPO is responsible for helping coordinate the broader U.S. vaccine and immunization system under the National Vaccine Plan, and it plays a central role in vaccine safety coordination through the Immunization Safety Task Force (ISTF). Through its work with ISTF partners and other vaccine safety stakeholders, NVPO identifies practical gaps in how vaccine safety is studied, monitored, and communicated. This grant was launched as a pilot cooperative agreement to fund targeted research intended to strengthen and modernize the U.S. vaccine safety enterprise, with an emphasis on work that can translate into clearer methods, better surveillance, and more consistent safety outcome definitions.
The main purpose of the program is to support research projects that address vaccine safety needs across several connected areas. Supported work can include generating safety profiles for new vaccines early in development, improving the safety of existing vaccines through modifications or updated approaches, and conducting applied research that directly improves real-world vaccine safety monitoring systems. A major theme is the development of consensus definitions for vaccine safety outcomes, which is important because inconsistent or poorly standardized outcome definitions make it difficult to compare studies, pool data across sites, or interpret safety findings consistently. By encouraging projects that develop or validate harmonized outcome definitions, NVPO is aiming to improve the quality and comparability of vaccine safety data not only in the United States, but also in global clinical research contexts where standardized definitions help align evidence across countries and research networks.
NVPO highlights a particular interest in vaccine safety projects involving vaccines recommended for, or expected to be routinely given to, pregnant women and/or newborns. Research topics may focus on the pregnant individual, the newborn, or both, and can span different stages of vaccine development and evaluation, including pre-clinical work, clinical research, and post-licensure monitoring. This priority reflects the unique scientific and public health importance of maternal and neonatal immunization, where safety monitoring often requires specialized methods, carefully defined outcomes, and long-term follow-up strategies that account for both maternal and infant health considerations.
Because this is a cooperative agreement rather than a typical grant, NVPO expects to be actively involved in the funded work beyond standard grants management oversight. NVPO scientific staff will provide guidance and support on study design and project development, offer scientific and programmatic input as the research activities proceed, and help connect awardees to relevant vaccine safety stakeholders. NVPO will also oversee whether adverse event following immunization research, monitoring approaches, analysis, and reporting are adequate, maintaining regular communication with the principal investigator and study team. In addition, NVPO plans to participate in preparing publications and public presentations that share findings from the funded project, reflecting the program goal of producing results that are usable, visible, and influential across the vaccine safety community.
From an administrative standpoint, the funding instrument is a Cooperative Agreement in the health category, listed under CFDA (now often referenced as Assistance Listing) 93.344. The opportunity anticipated making two awards, with no cost sharing or matching requirement. The award amounts were relatively focused for a pilot program, with a floor of $200,000 and a ceiling of $250,000. The opportunity was posted on January 13, 2015, created on March 18, 2015, and had a current closing date of April 15, 2015, with an archive date of May 15, 2015. Eligibility is listed broadly as "Others" with additional clarification referenced in the full announcement, and the legal authority for the program is section 1702(a) of the Public Health Service Act, as amended (42 U.S.C. 300u-1(a)).
Overall, this opportunity is best understood as a targeted, collaboration-heavy pilot investment aimed at improving how vaccine safety evidence is generated and standardized. It emphasizes practical outputs such as stronger monitoring methods, better adverse event assessment and analysis, and agreed-upon outcome definitions that can reduce ambiguity and improve comparability across studies, especially for vaccines used in pregnancy and early life where safety evaluation is both high priority and methodologically complex.
FAQs: FY15 Research, Monitoring and Outcomes Definitions for Vaccine Safety (OASH/NVPO)
What is the FY15 Research, Monitoring and Outcomes Definitions for Vaccine Safety opportunity?
This opportunity is a discretionary federal funding program from the Office of the Assistant Secretary for Health (OASH), managed through the National Vaccine Program Office (NVPO). It was launched as a pilot cooperative agreement to fund targeted research intended to strengthen and modernize the U.S. vaccine safety enterprise.
Which office manages this funding and what role does it play in vaccine safety?
The National Vaccine Program Office (NVPO) manages the opportunity. NVPO helps coordinate the broader U.S. vaccine and immunization system under the National Vaccine Plan and plays a central role in vaccine safety coordination through the Immunization Safety Task Force (ISTF).
Why was this pilot program created?
Through work with ISTF partners and other vaccine safety stakeholders, NVPO identifies practical gaps in how vaccine safety is studied, monitored, and communicated. This pilot was created to fund research that can translate into clearer methods, better surveillance, and more consistent vaccine safety outcome definitions.
What is the main purpose of the program?
The program supports research projects that address vaccine safety needs across connected areas, including research and applied work that improves real-world vaccine safety monitoring systems and strengthens the consistency of vaccine safety evidence.
What types of projects does the opportunity support?
Supported work can include generating safety profiles for new vaccines early in development, improving the safety of existing vaccines through modifications or updated approaches, and conducting applied research that directly improves vaccine safety monitoring systems.
Does the opportunity emphasize standardizing vaccine safety outcomes?
Yes. A major theme is developing consensus (harmonized) definitions for vaccine safety outcomes. NVPO highlights that inconsistent or poorly standardized outcome definitions can make it difficult to compare studies, pool data across sites, or interpret safety findings consistently.
Why are consensus outcome definitions important for vaccine safety research?
Consensus outcome definitions improve the quality and comparability of vaccine safety data. They help align how outcomes are defined and measured across studies and sites, making it easier to compare results, combine datasets, and interpret findings in a consistent way.
Is this opportunity relevant beyond the United States?
Yes. NVPO aims to improve comparability not only within the United States, but also in global clinical research contexts where standardized definitions help align evidence across countries and research networks.
Is there a specific population focus for this program?
NVPO expresses particular interest in vaccine safety projects involving vaccines recommended for, or expected to be routinely given to, pregnant women and/or newborns.
Can projects focus on pregnant individuals, newborns, or both?
Yes. Research topics may focus on the pregnant individual, the newborn, or both.
What stages of vaccine development and evaluation are in scope?
Projects can span pre-clinical work, clinical research, and post-licensure monitoring.
Why does the program prioritize maternal and neonatal immunization safety?
The opportunity notes the unique scientific and public health importance of maternal and neonatal immunization. Safety monitoring often requires specialized methods, carefully defined outcomes, and long-term follow-up strategies that account for both maternal and infant health considerations.
What funding instrument is used (grant vs. cooperative agreement)?
The funding instrument is a Cooperative Agreement (in the health category), meaning NVPO expects to be actively involved in the funded work beyond standard grants management oversight.
How will NVPO be involved during the project?
NVPO scientific staff will provide guidance and support on study design and project development, offer scientific and programmatic input as research proceeds, and help connect awardees to relevant vaccine safety stakeholders.
Will NVPO oversee the adequacy of safety monitoring and reporting?
Yes. NVPO will oversee whether adverse event following immunization research, monitoring approaches, analysis, and reporting are adequate, and will maintain regular communication with the principal investigator and study team.
Will NVPO participate in publications or presentations?
Yes. NVPO plans to participate in preparing publications and public presentations that share findings from the funded project, consistent with the goal of producing usable and visible results across the vaccine safety community.
What is the CFDA/Assistance Listing number for this opportunity?
The opportunity is listed under CFDA (now often referenced as Assistance Listing) 93.344.
How many awards were anticipated?
The opportunity anticipated making two awards.
What is the expected award size?
The award amounts were relatively focused for a pilot program, with a funding floor of $200,000 and a ceiling of $250,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
When was the opportunity posted and when did it close?
The opportunity was posted on January 13, 2015. The current closing date was April 15, 2015, and the archive date was May 15, 2015.
What are the key dates mentioned for this announcement?
Key dates provided include: posted January 13, 2015; created March 18, 2015; closing date April 15, 2015; archive date May 15, 2015.
Who is eligible to apply?
Eligibility is listed broadly as "Others," with additional clarification referenced in the full announcement.
What is the legal authority for this program?
The legal authority cited is section 1702(a) of the Public Health Service Act, as amended (42 U.S.C. 300u-1(a)).
What kinds of outputs is NVPO looking for from funded projects?
The opportunity emphasizes practical outputs such as stronger monitoring methods, better adverse event assessment and analysis, and agreed-upon outcome definitions that reduce ambiguity and improve comparability across studies.
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